The United States Food and Drug Administration (FDA) recently released its performance goals and procedures for fiscal years 2018 through 2022 for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization, known as BsUFA II. This goals letter represents the product of the FDA’s discussions with industry and public stakeholders and identifies commitments that apply to the aspects of the biosimilar biological product review program that are important for ensuring timely access to safe and effective biosimilar medicines for patients.
Through BsUFA II, the FDA strives to: ensure the effectiveness of the biosimilar biological product review program; advance development of biosimilar biological products through further clarification of the 351(k) regulatory pathway; enhance capacity for biosimilar regulations and guidance development, reviewer training, and timely communication; enhance management of user fee resources; and improve FDA hiring and retention of review staff.
Some of the key provisions found in the letter include: continue to improve the efficiency of the science-based FDA review process for biosimilars; establish dedicated staff capacity for key functions, such as facilitating scientific coordination, policy development, operations management, program governance, internal training, educational outreach, and communication; help ensure the long-term sustainability of BsUFA activities through modernized time reporting and capacity planning; and promote more informative engagement between FDA and biosimilar sponsors during development and review of biosimilar products, for example by helping to ensure feedback is provided in a timely manner.
PhRMA Reaction
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl issued a statement in support of the BsUFA II performance goals letter. He noted,
“The Biosimilar User Fee Act (BsUFA) is critical to supporting the U.S. Food and Drug Administration (FDA) in its core mission of protecting public health. Since its creation in 2012, BsUFA has helped benefit patient safety and public health as biosimilar products are required to meet FDA’s high standards for safety, purity and potency. The BsUFA II agreement will help provide FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients.”
He concluded, stating, “PhRMA looks forward to working with Congress, the administration, patient and medical provider groups, the FDA and all stakeholders to ensure timely reauthorization of this vital program.”
Support from BIO
Kay Holcombe, senior vice president of the Biotechnology Innovation Organization, expressed her support as well, saying,
“BIO and our member companies strongly supported the establishment of a pathway for the approval of biosimilars because we recognized that market entry of safe and effective biosimilars may provide increased choices for patients and physicians. We remain committed to ensuring the success of the emerging biosimilars market through our engagement in ongoing policy developments related to biosimilars, including our recent participation in the technical negotiations for the reauthorization of BsUFA.”
She continued, noting,
“Among the many enhancements to the biosimilars review process envisioned in the goals letter, we are particularly pleased with the Agency’s commitment to establish a program for enhanced communications during the biosimilars review process. A similar program in PDUFA has been tremendously successful in improving communications between Sponsors and the Agency at key points in the development process, resulting in a more efficient process for sponsors and the FDA alike.”
Public Meeting
The FDA will hold a public meeting on October 20, 2016, to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act. The meeting will be held from 9 am to 2 pm at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room, Silver Spring, MD 20993. If you would like to attend, the FDA asks you to register by October 19, 2016, here.